Gerson Lehrman Group: The FDA’s 510k clearance process (If it ain’t broke don’t fix it)!  (05/23/10):

Now,with the widespread acceptance of the Reprocessing Industry, used to reduce procedure costs to hospitals for the outsourcing of so-called “single-use” medical devices for sterilization, remanufacturing, reprocessing, repacking, and relabeling and the huge associated  to hospitals and purchasing  groups and consortiums, reducing the rrestrictions established by the FDA for 510k approval would reverse the progress we in the healthcare field have been seeking. Absolutely providing the highest level of care at the least expensive method. And, after all, isn’t this exactly what healthcare providers have been seeking?